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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY
Generic Namesystem, test, her-2/neu, ihc
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 e. innovation park dr.
tucson, AZ 85755
PMA NumberP990081
Supplement NumberS027
Date Received01/22/2014
Decision Date04/09/2014
Product Code MVC 
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDITION OF A CURRENT SENSE PRINTED CIRCUIT BOARD (PCB) TO THE BENCHMARK ULTRA INSTRUMENT THAT WILL PREVENT AN OVERCURRENT SITUATION.
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